Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. Gilteritinib's product information states that, before taking gilteritinib, relapsed or refactory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. The product information describes the mechanism of action for gilteritinib as inhibiting FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and that it induces apoptosis in leukemic cells expressing FLT3-ITD.

This is written in the approval document as:

Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

Citation

Astellas Pharma Europe B.V. Xospata (gilteritinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf. Revised November 2023. Accessed March 26, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	FLT3-ITD	Acute Myeloid Leukemia	Gilteritinib
EMA (1)	FLT3 p.D835Y	Acute Myeloid Leukemia	Gilteritinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-10-24	European Medicines Agency	Indication received approval from the European Commission.